The GMO law that treats the control of the genetically modified organisms (GMOs), which is passing its second reading in the Bulgarian Parliament, provoked significant interest in the media and the whole society. Because of its multidisciplinary feature (the law considers agricultural, environmental, health, trade, high-tech and in particular biotech-issues) and scientific specificity however, many aspects of its nature have been left apart from the awareness of the broad pubic and, unfortunately, from the understanding of the parliamentarians, to whom the legislative power has been assigned. This law however has an enormous economical, social and scientific importance for Bulgaria. This law could contribute to positioning Bulgaria among the countries with high developed technologies and economical prosperity or, in contrast, at the rear of Europe and the developing world.

1. GMOs: state-of-the-art

1.1. Global aspect

GMOs are organisms, produced by transferring, very often of one gene encoding a desirable trait, in one organism to another, through precise molecular biology technique, called genetic modification (in comparison with the classical breeding, in which an uncontrolled transfer of more than one genes occurs and many of the genes have unidentified effect on the resulting organism). GMOs appeared for the first time on the market in USA in 1994 According to the latest statistics, the global area with commercially grown transgenic plants is 81.0 million ha by 8.25 millions of farmers from 17 countries on 6 continents. /Source: Clive James, ISAAA, 2005/. It is worth to notice that 90% of the beneficiary farmers are resource- poor farmers from developing countries, whose increased incomes from biotech crops contributed to the alleviation of the poverty. The global market value of GM crops is estimated to 4.70 billion USD that represents 16% of the global seed market. The global value of the biotech market is projected at more than 5 billion USD for 2005, which ambiguously shows the considerable economical benefit of the modern biotechnologies. The main GM crops, grown worldwide are: soybean, maize, oilseed rape and cotton, while more than 45 other crops were approved as safe for human health and environment. World leaders in the commercial growth of GM crops are USA (59% from all cultivated area), followed by Argentina (20%), Canada (6%), Brazil (6%), China (5%), Paraguay (2%), India (1%), South Africa (1%), as well as Uruguay, Australia, Romania, Mexico, Spain and Philippines, (under 1%, but with areas over 50 000ha). A new generation of GM crops, related with the production of medicines, developed on the basis of gene transfer into plant or animal species, comes more and more into consideration.

1.2. Europe

In Europe, Romania and Spain grow transgenic crops on a commercial scale on area up to 100,000 ha. Germany, France and other countries from EU continue their field trials with biotech crops. In the period of 1999-2004, more than 17 000 field trials with transgenic plants have been performed in EU. In order to assess the risk and the benefits of biotechnology applications, the approach for case-by-case study has been adopted and the assessment is based on scientific state-of-the-art arguments. In the period July-October 2004, the EC found as safe 24 GM crops for food and feed under Regulation 1929/2003.

It is expected in the next 5 years the cultivated area with transgenic crops to reach 100 billion of ha in 25 countries and to ensure living of more than 10 billions of farmers. Countries like China, where the plant biotechnologies are national priority, Brazil (second world producer of soybean) and Pakistan, which has started collaboration with China on plant genomics in August 2003 with stating investment of 16.5 million USD will play increasing role in the global plant biotech arena.

1.3. Bulgaria

In 1996 Bulgaria adopted “Guideline for the dispersal of genetically modified higher plants, developed through DNA recombinant technology” (published in the State newspaper issue 72, 16.08.1996). It has been elaborated in accordance with the EU Directive 90/220. A Council for safety use of genetically modified higher plants started functioning, as enacted by the Guideline. Members of the Council were representatives from the Ministry of Agriculture and Forests, Ministry of Environment and Waters, Ministry of Health, the Executive agency for seed production, approbation and seed control, the National service for plant protection and agrichemistry as well as representatives from the scientific community. Chairman of the Council is the Minister of Agriculture and Forests, and Executive Secretary is a prominent scientist in the field of genetic engineering.

The development and implementation of the appropriate legislative framework made it possible the initiation of the estimation of biotech crops application in practice. In 1998, companies such as Novartis, Pioneer and Monsanto applied for granting approval for confined field trials of transgenic maize.

After the confined (small scale-) field trials were successfully carried out, in 1999 the Council started large scale field experiments with GM-maize.

Up to date, approvals for commercial planting of GMO have not been granted. Only large scale field trials with GM maize have been performed, which allowed the authorities to collect useful information and valuable experience with respect to the interactions of the transgenic plants with the environment and their impact on the human health.

A prerequisite for granting an approval for large scale field trials is the presence of a contract between the farmer and a company for export of the whole production into countries where the release and placing on the market of the respective GM crop is allowed.

For such purpose, a notifying company is obliged to inform the GM crop producer for the respective isolation distances between the conventional and transgenic fields (for maize they are at least 50 m) and the methods for post-harvest handling and transportation.

2. The Biosafety Protocol

The Cartagena Protocol on Biosafety has been adopted under the international Convention on Biodiversity. Its objective is to contribute to the regulation of the transboundary movement of the living modified organisms in the context of protection of biodiversity in a specific country of import, taking into account risks to human health

A fact with particular importance for Bulgaria is that the country is among first that have signed this international agreement on May, 24th 2000. One of the main provisions of the Protocol is the so called advanced informed agreement procedure, which requires that the country of export should inform officially the country of import for its intentions for import or transit transfer of GMOs on the territory of the country of import. The country of import is obliged to provide with an official response within 270 days whether such transfer is allowed or not. The refusal, if any, should be science based. In the case Bulgaria would not have signed the Protocol, the country would not have had the legal right to refuse the import of GM production being then in infringement of the provisions of the WTO – TBT agreement as putting technical barrier to the world trade. This is the actual reason why the Biosafety protocol has found such wide international support, including the biggest ecological non-governmental organisations such as “Green peace” and “Friends of the Earth”, which have repeatingly urged for ratification of the Protocol, with special emphasis on developing countries.

Other fact, which requires serious commitment and responsibility is that Bulgaria is among the first Member-States that not only have signed the Protocol but is the first country in the world, whose Parliament has ratified the agreement in October, 13th 2000. With this act, Bulgaria took the obligation to adopt appropriate legal framework in order to ensure the fulfillment of the Protocol’s provisions since the first day of the Protocol’s entry into force. Taking into consideration the fact that the Biosafety Protocol entered into force in September, 11th 2003 and 5 years after its ratification, Bulgaria is unable to comply with it, not only derogates from Bulgaria’s reputation, but would also burden the country with serious international sanctions in this regard.

3. Bulgarian GMO law

The GMO law, which is passing its second reading in the Bulgarian parliament should combine the international obligations of the country with the particularities of the local legislative system and the Directives of the European Commission in order to implement its major function: ensuring control on the import, trade and use of GMOs to guarantee their safe use for human health and environment.

It is necessary to mention that the draft GMO law, before the modifications during the second reading, complied with all existing appropriate EU Directives and international agreements. It has been prepared by qualified professionals- lawyers, experts and scientists from the Ministry of Agriculture and Forests, Ministry of Environment and Waters, Ministry of Health, Ministry of Economy, Ministry of Education and Science, the Executive agency for seed production, approbation and seed control, and the National Center for Agricultural Sciences. Before the submission of the draft GMO law in the Parliament, it has been revised and positively estimated by leading international experts in this field from EU and UN organizations. 4. What happened in the Parliament?

The parliamentarian Commission of the Environment and Waters, for reasons hard to understand, has added some articles that are completely inconsistent with the legislative biosafety framework in European Union. These are namely:
А. Article 77a (1), which has been already adopted on the second reading, states: The deliberate release and the placing on the market of the following GMOs: tobacco, grape, cotton, oil rose, wheat and all vegetables and fruits is prohibited .
Nowhere in the world, including the EU-Member-States prohibitions for deliberate release of specific crops are in place but rather options for refusal for deliberate release into the environment and placing on the market after the performance of specific procedure: notification with providing a detailed dossier; checking the dossier for completeness; performance of science based risk assessment and decision upon risk-benefit of the competent national authority (which is political and may not be based only on the scientific results).
Moreover, such a prohibition can be easily interpreted as confrontation with EU policy and as a technical barrier to international trade (according to the TBT- WTO- agreement) and thus, Bulgaria risks to bear severe international sanctions. It might be useful to remind that since 2003 USA, Canada, Argentina, Egypt and other countries brought an accusation against EU, which relates to the delay of the procedure for granting an approval/ban for placing on the market of GMOs, the so called de facto moratorium. Influenced by this international pressure, 24 GM plant varieties were considered safe for placing on the EU market as food and feed in the period July- October 2004, which marks serious liberalization in the EU policy in the field of biotechnologies.
B. Article 51 (2) states: The Minister of Environment and Waters refuses to grant consent for deliberate release of GMO into the environment when there is a neighbour field with organic production.

In relevance with the EU Common Agricultural Policy (CAP) and the principles of the co-existence of conventional, organic and GMO based agriculture, announced in July 2003 by EC, the European agriculture will be grounded upon the equality of rights of all of the three type of production, thus ensuring a high degree of consumer and farmer choice. Instead of prohibitions, Europe builds polices and invests in developing of science-based approaches to guarantee co-existence of all types of good agricultural practices. On the contrary, according to the latest statistics, Bulgaria takes the lowest place in Europe for investments in science, and moreover, the agricultural science since long has been neglected by the ruling circles in the country.
C. Apotheosis of the inquisitional policy against the biotechnological science, proclaimed by the present form of the GMO law, is however the article 3a from the additional provisions, which states: The genetic modifications with animals, oil rose, grape and tobacco are prohibited on the territory of Republic of Bulgaria that practically prohibits the even the work in contained, strictly controlled laboratory conditions with any animals, oil rose, grape or tobacco, when the method of genetic transformation is used.

Today, in the age of the active sequencing of the genomes of the organisms, in time, when the mankind is on the verge of the disclosure of gene functions, a fact resulting finally in liquidation of important diseases like cancer and AIDS and in the consumption of healthier food and feed, no other country in the world can afford the short-sightedness to put a ban on carrying scientific experiments with specific animal of plant species, especially in the case, in which such species are priority for the country’s economy! The only precedent in the modern history was the Lysenko’s period in the USSR in the 60s, when the genetics has been politically denied and destroyed and the science has been brought back with several decades!

We would like to believe that articles, which harm directly scientific applications such as genetics, biotechnology, genomics, proteomics, but carrying indirect threat to health care, nutrition, and economy among others, could not be part of the legislative system of any modern society!